REFINE-B Study
Research type
Research Study
Full title
REgimen optimisation: Feasibility of sImplifying NucleotidE therapy in HIV/HBV coinfection (REFINE-B study)
IRAS ID
1004892
Contact name
Kosh Agarwal
Contact email
Eudract number
2021-005910-32
ISRCTN Number
ISRCTN11675563
Research summary
People with HIV have traditionally been recommended to take three drugs for adequate control of the virus. However,
many can now take only two drugs, such as dolutegravir plus lamivudine, without needing a third drug such as
tenofovir. This carries benefits – both drugs can be combined into one pill daily, with fewer side effects on the kidneys
than sometimes occur with tenofovir. Taking two drugs is also cheaper than taking a three-drug regimen including the
new form of tenofovir (TAF). However, people with HIV plus hepatitis B (HBV) have to take tenofovir, or another drug
called entecavir. This is due to concerns that HBV won’t be treated well enough without this drug being included.
Using new blood markers for HBV, called pgRNA and HBcrAg, studies have shown we can group patients with HBV
into those who could stop tenofovir or entecavir and those who should not. Those with undetectable HBV viral load,
pgRNA and HBcrAg may be able to stop, but if the viral load, pgRNA or HBcrAg is detectable, they should carry on
tenofovir/entecavir. However, we don’t know yet if this strategy could work in people who have both HIV and HBV
together.
This study is a small scale study to evaluate whether or not it is acceptable to reduce the number of drugs for treating
HIV/HBV in people with undetectable HBV viral load, pgRNA and HBcrAg. We will recruit 12 people who will stop
tenofovir or entecavir but continue their other antivirals. Individuals will be followed up closely for 6 months, and then
tenofovir/entecavir will be restarted. We will measure viral markers and liver tests in the blood. If results show the
strategy to be acceptable, they will help us set up a larger randomised trial to provide more information as to whether
or not the strategy is effectiveREC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0184
Date of REC Opinion
8 Jul 2022
REC opinion
Further Information Favourable Opinion